CE 7smart USP Apparatus 4 - Flow Through Cell Dissolution from SOTAX

Description

Your Experts in USP Apparatus 4 Flow Through Dissolution Testing

New types of formulations and drug delivery technologies call for a new approach to in-vitro drug release testing. Traditional dissolution methods are not tailored to these novel dosage forms. The flow through technique is able to fulfill the requirements of such complex formulations. Its flexibility and ability to characterize the release properties of a wide variety of formulations make it a powerful tool for pharmaceutical development.

In the Flow-Through Method, the test sample is located in a small volume cell through which media is pumped at a temperature of 37 °C. The eluate is filtered upon leaving the cell and then can be analyzed directly or collected in fractions to calculate the percent drug release. The SOTAX CE7 smart can be set up in “open loop” or “closed loop” configurations. Open Loop is generally used for poorly soluble compounds when fresh media flows across the dosage form or when multiple media change methods are required. In closed loop, the Flow Through Method is conducted much like USP Apparatus 1 and 2 where a fixed volume of media circulates across the dosage form. In each configuration, the sample can be automatically collected with a fraction collector or autosampler or analyzed with an in-line UV-Vis spectrophotometer.

The Flow Through Dissolution Method is approved for use and accepted by the FDA and USP for a wide range of formulations including:

  • ER/MR Tablets and Capsules
  • APIs, Powders, Granules
  • Injectable Suspensions
  • IVIVC Studies
  • Poorly Soluble Compounds
  • Soft Gelatin Capsules
  • Suppositories
  • Implants
  • Drug Eluting Stents
  • Drug Coated Medical Devices
  • Semi-Solids
  • Gels
  • Microspheres
  • Nanoparticles
  • Liposomes
  • Ophthalmic Devices
  • Low Dose/Small Volume Dissolution Testing